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Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035) (ENCORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00705614
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : August 26, 2014
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Crohn's Disease
Intervention Biological: Remicade
Enrollment 2662
Recruitment Details The Standard Therapy group includes both those who stayed on Standard Therapy and those who switched to Remicade after starting on Standard Therapy. Two hundred ninety-eight of the 1121 subjects enrolled in the Standard Therapy Group switched to Remicade during follow-up.
Pre-assignment Details  
Arm/Group Title Remicade Standard Therapy Group
Hide Arm/Group Description Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.

Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.

Some participants who start in the Standard Therapy Group switched over to Remicade sometime during the follow-up period. Participants who switched to Remicade were evaluated in the Standard Therapy group until the time of the switch and were evaluated in the Switched to Remicade group thereafter.

Period Title: Initial Intervention
Started 1541 1121
Completed 1023 800
Not Completed 518 321
Reason Not Completed
Adverse Event             40             21
Lost to Follow-up             310             191
Withdrawal by Subject             114             71
Administrative Reason             51             38
Status completion unknown             3             0
Period Title: Switch to Remicade
Started 0 298
Completed 0 249
Not Completed 0 49
Reason Not Completed
Adverse Event             0             5
Lost to Follow-up             0             23
Withdrawal by Subject             0             12
Administrative Reason             0             9
Arm/Group Title Remicade Standard Therapy Group Total
Hide Arm/Group Description Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade. The Standard Therapy group includes both those who stayed on Standard Therapy and those who switched to Remicade after starting on Standard Therapy. Two hundred ninety-eight of the 1121 subjects enrolled in the Standard Therapy Group switched to Remicade during follow-up. Total of all reporting groups
Overall Number of Baseline Participants 1541 1121 2662
Hide Baseline Analysis Population Description
298 of the 1121 participants enrolled in the Standard Therapy Group switched to Remicade during follow-up. They are included in both the Standard Therapy and Switched to Remicade treatment groups, but baseline measures (obtained at the time of their switch to Remicade) are shown as separate rows in the Baseline Measures table.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1541 participants 1121 participants 2662 participants
All Participants 36.1  (12.90) 37.5  (12.86) 36.7  (12.90)
Switched to Remicade NA [1]   (NA) 36.7  (12.3) 36.7  (12.3)
[1]
Not available (N/A) because there are no participants in this group.
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1541 participants 1121 participants 2662 participants
Female (All Participants) 935 677 1612
Male (All Participants) 606 444 1050
Female (Switched to Remicade) NA [1]  191 NA [2] 
Male (Switched to Remicade) NA [1]  107 NA [2] 
[1]
Not available (N/A) because there are no participants in this group.
[2]
Total not calculated because data are not available (NA) in one or more arms.
1.Primary Outcome
Title Number of Participants With Serious Infections
Hide Description The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii [PCP] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Measure Type: Number
Unit of Measure: Participants
132 47 18
2.Primary Outcome
Title Number of Participants With Infusion-Related Reactions/Hypersensitivity
Hide Description The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Measure Type: Number
Unit of Measure: Participants
173 1 28
3.Primary Outcome
Title Number of Participant Fatalities
Hide Description The number of participant fatalities was evaluated throughout the study.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Measure Type: Number
Unit of Measure: Participants
30 14 4
4.Primary Outcome
Title Number of Participants With New or Worsening Congestive Heart Failure
Hide Description The number of participants with new or worsening congestive heart failure was evaluated throughout the study.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Measure Type: Number
Unit of Measure: Participants
1 1 0
5.Primary Outcome
Title Number of Participants With Demyelinating Neurological Disorders
Hide Description The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Measure Type: Number
Unit of Measure: Participants
4 1 0
6.Primary Outcome
Title Number of Participants With Hematologic Conditions
Hide Description The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Measure Type: Number
Unit of Measure: Participants
50 11 7
7.Primary Outcome
Title Number of Participants With Lymphoproliferative Disorders/Malignancies
Hide Description The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Measure Type: Number
Unit of Measure: Participants
49 21 8
8.Secondary Outcome
Title Participant Assessment of Overall Health Status By Study Visit
Hide Description The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants with a Participant Assessment of Overall Health Index score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Visit 1 (Baseline; n=1526, 1116, 0) 4.3  (1.33) 3.9  (1.38) NA [1]   (NA)
Visit 2 (n=1344, 903, 95) 3.3  (1.44) 3.3  (1.44) 3.9  (1.49)
Visit 3 (n=1280, 809, 146) 3.2  (1.41) 3.1  (1.40) 3.6  (1.41)
Visit 4 (n=1217, 755, 162) 3.2  (1.43) 3.0  (1.38) 3.5  (1.45)
Visit 5 (n=1160, 704, 184) 3.1  (1.44) 3.1  (1.42) 3.2  (1.52)
Visit 6 (n=1110, 649, 202) 3.1  (1.43) 3.0  (1.41) 3.4  (1.44)
Visit 7 (n=1046, 606, 212) 3.1  (1.47) 3.0  (1.41) 3.3  (1.42)
Visit 8 (n=1044, 573, 221) 3.1  (1.46) 3.0  (1.44) 3.2  (1.43)
Visit 9 (n=999, 544, 223) 3.1  (1.45) 2.9  (1.41) 3.2  (1.50)
Visit 10 (n=963, 520, 227) 3.0  (1.42) 2.8  (1.44) 3.1  (1.38)
Visit 11 (n=956, 527, 235) 3.0  (1.41) 2.8  (1.43) 3.1  (1.47)
[1]
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
9.Secondary Outcome
Title The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Hide Description The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants with a Harvey-Bradshaw Index of Crohn's Disease score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Visit 1 (Baseline; n=1505, 1106, 0) 8.2  (5.36) 6.2  (4.94) NA [1]   (NA)
Visit 2 (n=1320, 876, 91) 4.1  (4.13) 3.8  (3.84) 6.0  (5.28)
Visit 3 (n=1250, 785, 143) 3.7  (3.87) 3.5  (3.64) 4.4  (4.05)
Visit 4 (n=1196, 742, 159) 3.8  (4.01) 3.2  (3.56) 4.8  (4.47)
Visit 5 (n=1127, 692, 181) 3.7  (3.95) 3.4  (3.51) 4.9  (5.81)
Visit 6 (n=1070, 647, 199) 3.6  (4.00) 3.1  (3.39) 4.5  (4.29)
Visit 7 (n=1023, 592, 209) 3.6  (4.00) 3.0  (3.36) 4.1  (4.43)
Visit 8 (n=1015, 562, 224) 3.6  (3.97) 3.2  (3.63) 4.1  (4.69)
Visit 9 (n=953, 546, 219) 3.6  (4.50) 2.9  (2.90) 4.4  (5.23)
Visit 10 (n=936, 526, 225) 3.4  (4.23) 2.7  (3.38) 4.3  (4.66)
Visit 11 (n=918, 525, 238) 3.4  (3.93) 2.7  (3.44) 4.2  (4.29)
[1]
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
10.Secondary Outcome
Title Work/Daily Activity Status Score By Study Visit
Hide Description The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants with a work/daily activity status score at baseline and each study visit. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Visit 1 (Baseline; n=1496, 1108, 0) 5.9  (2.61) 4.9  (2.83) NA [1]   (NA)
Visit 2 (n=1316, 895, 94) 4.2  (2.86) 3.7  (2.79) 5.5  (2.81)
Visit 3 (n=1235, 797, 143) 3.8  (2.76) 3.2  (2.77) 4.8  (2.94)
Visit 4 (n=1192, 738, 159) 3.6  (2.79) 2.9  (2.60) 4.3  (2.95)
Visit 5 (n=1128, 694, 179) 3.4  (2.76) 3.0  (2.63) 4.0  (2.89)
Visit 6 (n=1077, 638, 201) 3.3  (2.75) 2.7  (2.56) 3.9  (2.87)
Visit 7 (n=1030, 601, 207) 3.2  (2.70) 2.8  (2.62) 3.6  (2.85)
Visit 8 (n=1025, 571, 221) 3.3  (2.75) 2.7  (2.59) 3.5  (2.74)
Visit 9 (n=982, 542, 222) 3.3  (2.75) 2.6  (2.46) 3.5  (2.78)
Visit 10 (n=934, 514, 225) 3.1  (2.66) 2.4  (2.53) 3.6  (2.71)
Visit 11 (n=925, 521, 235) 3.2  (2.67) 2.4  (2.44) 3.6  (2.76)
[1]
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
11.Secondary Outcome
Title Number of Participants With a Draining Fistula By Study Visit
Hide Description The number of participants with a draining fistula was evaluated at each study visit.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants with fistula status data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Measure Type: Number
Unit of Measure: Participants
Visit 1 (Baseline; n=1541, 1120, 0) 349 96 NA [1] 
Visit 2 (n=1420, 920, 100) 211 51 16
Visit 3 (n=1334, 827, 152) 170 41 19
Visit 4 (n=1285, 779, 168) 146 31 12
Visit 5 (n=1221, 714, 188) 125 29 15
Visit 6 (n=1169, 666, 208) 114 26 15
Visit 7 (n=1110, 615, 219) 97 31 15
Visit 8 (n=1097, 588, 233) 105 23 16
Visit 9 (n=1046, 562, 229) 98 32 15
Visit 10 (n=1030, 535, 235) 85 15 20
Visit 11 (n=1006, 541, 248) 87 16 20
[1]
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
12.Secondary Outcome
Title Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Hide Description The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants with hospital stay data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Mean (Standard Deviation)
Unit of Measure: Hospital Stays
Visit 1 (Baseline; n=1539, 1121, 0) 0.7  (1.25) 0.5  (0.81) NA [1]   (NA)
Visit 2 (n=1418, 920, 100) 0.3  (0.87) 0.2  (0.50) 0.5  (0.76)
Visit 3 (n=1334, 827, 152) 0.3  (0.92) 0.1  (0.38) 0.4  (0.86)
Visit 4 (n=1285, 779, 168) 0.2  (0.56) 0.2  (3.08) 0.2  (0.67)
Visit 5 (n=1221, 714, 188) 0.1  (0.54) 0.1  (0.28) 0.3  (0.72)
Visit 6 (n=1170, 665, 208) 0.1  (0.66) 0.1  (0.33) 0.1  (0.49)
Visit 7 (n=1111, 615, 219) 0.1  (0.40) 0.1  (0.43) 0.2  (0.55)
Visit 8 (n=1099, 589, 233) 0.1  (0.76) 0.1  (0.42) 0.1  (0.49)
Visit 9 (n=1046, 562, 229) 0.1  (0.68) 0.1  (0.50) 0.1  (0.31)
Visit 10 (n=1031, 535, 235) 0.1  (0.46) 0.1  (0.42) 0.1  (0.44)
Visit 11 (n=1006, 541, 248) 0.1  (0.35) 0.1  (2.59) 0.1  (0.42)
[1]
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
13.Secondary Outcome
Title Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Hide Description The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants with hospital stay duration data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Mean (Standard Deviation)
Unit of Measure: Days
Visit 1 (Baseline; n=657,418 ,0) 12.2  (13.73) 10.8  (10.93) NA [1]   (NA)
Visit 2 (n=304,126, 33) 14.4  (17.81) 12.0  (14.26) 13.0  (12.23)
Visit 3 (n=216, 58, 35) 14.2  (16.83) 9.4  (7.49) 13.5  (13.65)
Visit 4 (n=151, 60, 24) 12.6  (15.23) 8.5  (11.87) 9.1  (10.82)
Visit 5 (n=105, 35, 34) 11.7  (13.02) 9.8  (9.49) 7.1  (6.21)
Visit 6 (n=107, 49, 19) 10.8  (17.33) 13.7  (27.34) 18.3  (17.81)
Visit 7 (n=109, 45, 25) 10.6  (14.41) 10.2  (10.63) 10.0  (11.33)
Visit 8 (n=98, 29, 23) 9.5  (9.04) 16.3  (15.52) 14.7  (17.29)
Visit 9 (n=80, 38, 17) 12.4  (14.44) 6.9  (5.77) 10.7  (17.20)
Visit 10 (n=85, 29, 27) 10.1  (12.02) 8.0  (5.41) 9.0  (6.40)
Visit 11 (n=63, 19, 18) 11.4  (13.24) 8.7  (10.64) 18.1  (31.57)
[1]
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
14.Secondary Outcome
Title Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Hide Description The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.
Time Frame Up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants with surgical procedure data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
Arm/Group Title Remicade Standard Therapy Switched to Remicade
Hide Arm/Group Description:
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
Overall Number of Participants Analyzed 1541 1121 298
Measure Type: Number
Unit of Measure: Surgical Procedures
Visit 1 (Basline; n=660, 419, 0) 171 81 NA [1] 
Visit 2 (n=304, 126, 33) 135 51 7
Visit 3 (n=217, 57, 36) 121 23 12
Visit 4 (n=153, 60, 24) 68 16 8
Visit 5 (n=106, 36, 34) 50 14 14
Visit 6 (n=108, 49, 19) 49 21 11
Visit 7 (n=109, 45, 25) 48 20 6
Visit 8 (n=98, 29, 23) 43 12 7
Visit 9 (n=82, 38, 17) 38 13 8
Visit 10 (n=85, 29, 27) 38 13 8
Visit 11 (n=63, 19, 18) 34 6 8
[1]
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
Time Frame Up to 5 Years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Therapy Remicade Switched to Remicade
Hide Arm/Group Description Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment. Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
All-Cause Mortality
Standard Therapy Remicade Switched to Remicade
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Standard Therapy Remicade Switched to Remicade
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   391/1121 (34.88%)      792/1541 (51.40%)      136/298 (45.64%)    
Blood and lymphatic system disorders       
ANAEMIA  1  5/1121 (0.45%)  6 9/1541 (0.58%)  11 1/298 (0.34%)  1
ANAEMIA HAEMOLYTIC AUTOIMMUNE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ANAEMIA VITAMIN B12 DEFICIENCY  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
BONE MARROW FAILURE  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
FEBRILE NEUTROPENIA  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
HAEMOLYSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
HAEMOLYTIC URAEMIC SYNDROME  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
HAEMORRHAGIC ANAEMIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  1
IRON DEFICIENCY ANAEMIA  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 0/298 (0.00%)  0
LEUKOPENIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LYMPHADENITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LYMPHADENOPATHY  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
MICROCYTIC ANAEMIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
NEUTROPENIA  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
PANCYTOPENIA  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 1/298 (0.34%)  1
THROMBOCYTOPENIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
THROMBOTIC THROMBOCYTOPENIC PURPURA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
THYMUS DISORDER  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
Cardiac disorders       
ACUTE CORONARY SYNDROME  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
ACUTE MYOCARDIAL INFARCTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ANGINA PECTORIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  1
ATRIAL FIBRILLATION  1  3/1121 (0.27%)  4 0/1541 (0.00%)  0 0/298 (0.00%)  0
CARDIAC FAILURE  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
CARDIAC FAILURE CONGESTIVE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  2 0/298 (0.00%)  0
CARDIAC VALVE DISEASE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MYOCARDIAL INFARCTION  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 1/298 (0.34%)  1
PERICARDITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PLEUROPERICARDITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
SUPRAVENTRICULAR TACHYCARDIA  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
TACHYARRHYTHMIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
TACHYCARDIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
Congenital, familial and genetic disorders       
CONGENITAL ANOMALY IN OFFSPRING  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
ENCEPHALOCELE  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
HAEMANGIOMA CONGENITAL  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
HIP DYSPLASIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PRETERNATURAL ANUS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
PYLORIC STENOSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
Ear and labyrinth disorders       
HYPOACUSIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
VERTIGO  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
Endocrine disorders       
ADRENOCORTICAL INSUFFICIENCY ACUTE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  2 0/298 (0.00%)  0
GOITRE  1  3/1121 (0.27%)  3 1/1541 (0.06%)  1 0/298 (0.00%)  0
HYPERPARATHYROIDISM  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
HYPOTHYROIDISM  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
Eye disorders       
CATARACT  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
COLOUR BLINDNESS ACQUIRED  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
UVEITIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
Gastrointestinal disorders       
ABDOMINAL ADHESIONS  1  0/1121 (0.00%)  0 4/1541 (0.26%)  5 0/298 (0.00%)  0
ABDOMINAL DISTENSION  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
ABDOMINAL HERNIA  1  1/1121 (0.09%)  1 7/1541 (0.45%)  7 2/298 (0.67%)  2
ABDOMINAL PAIN  1  29/1121 (2.59%)  30 42/1541 (2.73%)  49 9/298 (3.02%)  10
ABDOMINAL PAIN LOWER  1  2/1121 (0.18%)  2 1/1541 (0.06%)  1 1/298 (0.34%)  1
ABDOMINAL PAIN UPPER  1  4/1121 (0.36%)  4 5/1541 (0.32%)  5 1/298 (0.34%)  1
ACUTE ABDOMEN  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ANAL FISSURE  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 1/298 (0.34%)  1
ANAL FISTULA  1  11/1121 (0.98%)  18 47/1541 (3.05%)  57 4/298 (1.34%)  5
ANAL HAEMORRHAGE  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
ANAL SKIN TAGS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ANAL SPHINCTER ATONY  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
ANAL STENOSIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
ANOGENITAL DYSPLASIA  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
ANOVULVAR FISTULA  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
APHTHOUS STOMATITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  1
ASCITES  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
BILE ACID MALABSORPTION  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
COLITIS  1  6/1121 (0.54%)  6 8/1541 (0.52%)  8 1/298 (0.34%)  1
COLITIS ULCERATIVE  1  1/1121 (0.09%)  1 3/1541 (0.19%)  4 0/298 (0.00%)  0
COLONIC FISTULA  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 0/298 (0.00%)  0
COLONIC OBSTRUCTION  1  0/1121 (0.00%)  0 2/1541 (0.13%)  3 0/298 (0.00%)  0
COLONIC STENOSIS  1  2/1121 (0.18%)  2 8/1541 (0.52%)  9 2/298 (0.67%)  3
CONSTIPATION  1  2/1121 (0.18%)  2 5/1541 (0.32%)  5 0/298 (0.00%)  0
CROHN'S DISEASE  1  131/1121 (11.69%)  164 298/1541 (19.34%)  460 47/298 (15.77%)  67
DIARRHOEA  1  6/1121 (0.54%)  6 11/1541 (0.71%)  12 4/298 (1.34%)  4
DIARRHOEA HAEMORRHAGIC  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
DUODENAL STENOSIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
ENTERITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ENTEROCOLITIS  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
ENTEROCOLONIC FISTULA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ENTEROCUTANEOUS FISTULA  1  3/1121 (0.27%)  6 7/1541 (0.45%)  9 1/298 (0.34%)  1
ENTEROVESICAL FISTULA  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 0/298 (0.00%)  0
FAECAL INCONTINENCE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
FAECALOMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  1
FLATULENCE  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 1/298 (0.34%)  1
FOOD POISONING  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
FREQUENT BOWEL MOVEMENTS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
GASTRIC ULCER  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 1/298 (0.34%)  1
GASTRIC ULCER HAEMORRHAGE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
GASTRITIS  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
GASTRODUODENAL ULCER  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
GASTROINTESTINAL DISORDER  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
GASTROINTESTINAL DYSPLASIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
GASTROINTESTINAL FISTULA  1  2/1121 (0.18%)  2 2/1541 (0.13%)  2 0/298 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE  1  1/1121 (0.09%)  1 3/1541 (0.19%)  7 1/298 (0.34%)  1
GASTROINTESTINAL HYPOMOTILITY  1  0/1121 (0.00%)  0 2/1541 (0.13%)  3 0/298 (0.00%)  0
GASTROINTESTINAL INFLAMMATION  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 1/298 (0.34%)  1
GASTROINTESTINAL MOTILITY DISORDER  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
GASTROINTESTINAL OBSTRUCTION  1  2/1121 (0.18%)  2 0/1541 (0.00%)  0 0/298 (0.00%)  0
GASTROINTESTINAL PAIN  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
GASTROINTESTINAL STENOSIS  1  7/1121 (0.62%)  8 9/1541 (0.58%)  15 3/298 (1.01%)  3
GASTROINTESTINAL TOXICITY  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
HAEMATEMESIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  1
HAEMORRHOIDAL HAEMORRHAGE  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
HERNIAL EVENTRATION  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
ILEAL FISTULA  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 2/298 (0.67%)  2
ILEAL PERFORATION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ILEAL STENOSIS  1  20/1121 (1.78%)  21 41/1541 (2.66%)  45 9/298 (3.02%)  10
ILEITIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
ILEUS  1  12/1121 (1.07%)  13 17/1541 (1.10%)  19 4/298 (1.34%)  5
INFLAMMATORY BOWEL DISEASE  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
INGUINAL HERNIA  1  4/1121 (0.36%)  4 0/1541 (0.00%)  0 0/298 (0.00%)  0
INTESTINAL ANGINA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
INTESTINAL FISTULA  1  2/1121 (0.18%)  2 7/1541 (0.45%)  7 1/298 (0.34%)  1
INTESTINAL HAEMORRHAGE  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
INTESTINAL INFARCTION  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
INTESTINAL OBSTRUCTION  1  9/1121 (0.80%)  10 36/1541 (2.34%)  44 4/298 (1.34%)  4
INTESTINAL PERFORATION  1  1/1121 (0.09%)  1 2/1541 (0.13%)  3 0/298 (0.00%)  0
INTESTINAL POLYP  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
INTESTINAL STENOSIS  1  8/1121 (0.71%)  8 15/1541 (0.97%)  16 3/298 (1.01%)  3
INTUSSUSCEPTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
JEJUNAL STENOSIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 2/298 (0.67%)  3
LARGE INTESTINAL HAEMORRHAGE  1  0/1121 (0.00%)  0 2/1541 (0.13%)  3 0/298 (0.00%)  0
LARGE INTESTINAL ULCER  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LARGE INTESTINE PERFORATION  1  2/1121 (0.18%)  2 9/1541 (0.58%)  9 1/298 (0.34%)  1
LARGE INTESTINE POLYP  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  2
MALABSORPTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MECHANICAL ILEUS  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
MELAENA  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
MESENTERIC OCCLUSION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MESENTERIC VASCULAR INSUFFICIENCY  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
NAUSEA  1  3/1121 (0.27%)  3 7/1541 (0.45%)  7 1/298 (0.34%)  1
OESOPHAGEAL VARICES HAEMORRHAGE  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
PANCREATITIS  1  5/1121 (0.45%)  5 6/1541 (0.39%)  8 1/298 (0.34%)  1
PANCREATITIS ACUTE  1  2/1121 (0.18%)  2 0/1541 (0.00%)  0 1/298 (0.34%)  4
PEPTIC ULCER HAEMORRHAGE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
POUCHITIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
PROCTALGIA  1  0/1121 (0.00%)  0 5/1541 (0.32%)  7 0/298 (0.00%)  0
PROCTITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PROCTOCOLITIS  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
RECTAL HAEMORRHAGE  1  4/1121 (0.36%)  4 3/1541 (0.19%)  3 1/298 (0.34%)  1
RECTAL PROLAPSE  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
RECTAL STENOSIS  1  1/1121 (0.09%)  1 2/1541 (0.13%)  2 0/298 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION  1  8/1121 (0.71%)  9 16/1541 (1.04%)  17 1/298 (0.34%)  1
SMALL INTESTINAL PERFORATION  1  1/1121 (0.09%)  1 3/1541 (0.19%)  3 0/298 (0.00%)  0
SMALL INTESTINAL STENOSIS  1  2/1121 (0.18%)  2 2/1541 (0.13%)  2 1/298 (0.34%)  1
STOMATITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
SUBILEUS  1  11/1121 (0.98%)  13 17/1541 (1.10%)  21 6/298 (2.01%)  7
UMBILICAL HERNIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
UPPER GASTROINTESTINAL HAEMORRHAGE  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
VOMITING  1  4/1121 (0.36%)  4 10/1541 (0.65%)  10 1/298 (0.34%)  1
General disorders       
ADHESION  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
ADVERSE DRUG REACTION  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
ASTHENIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  1
CARDIAC DEATH  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
CONDITION AGGRAVATED  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
CYST  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
DEATH NEONATAL  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
DRUG INEFFECTIVE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
DRUG INTOLERANCE  1  1/1121 (0.09%)  1 2/1541 (0.13%)  2 0/298 (0.00%)  0
FATIGUE  1  1/1121 (0.09%)  1 2/1541 (0.13%)  2 0/298 (0.00%)  0
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/1121 (0.00%)  0 4/1541 (0.26%)  4 0/298 (0.00%)  0
HERNIA  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 1/298 (0.34%)  1
IMPAIRED HEALING  1  2/1121 (0.18%)  2 3/1541 (0.19%)  3 0/298 (0.00%)  0
INFLAMMATION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LOCALISED OEDEMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MALAISE  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 2/298 (0.67%)  3
MEDICAL DEVICE COMPLICATION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MULTI-ORGAN FAILURE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
NECROSIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
NON-CARDIAC CHEST PAIN  1  4/1121 (0.36%)  4 2/1541 (0.13%)  2 2/298 (0.67%)  2
OEDEMA  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
OEDEMA PERIPHERAL  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 0/298 (0.00%)  0
PYREXIA  1  9/1121 (0.80%)  10 16/1541 (1.04%)  19 4/298 (1.34%)  4
SEROSITIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
SUDDEN DEATH  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
Hepatobiliary disorders       
AUTOIMMUNE HEPATITIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
BILE DUCT STENOSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
BILE DUCT STONE  1  1/1121 (0.09%)  2 1/1541 (0.06%)  1 0/298 (0.00%)  0
BILIARY COLIC  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
CHOLANGITIS  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 1/298 (0.34%)  1
CHOLANGITIS SCLEROSING  1  1/1121 (0.09%)  2 1/1541 (0.06%)  2 1/298 (0.34%)  2
CHOLECYSTITIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  3 1/298 (0.34%)  1
CHOLECYSTITIS ACUTE  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
CHOLECYSTITIS CHRONIC  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
CHOLECYSTOCHOLANGITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  2 0/298 (0.00%)  0
CHOLELITHIASIS  1  5/1121 (0.45%)  5 8/1541 (0.52%)  8 2/298 (0.67%)  2
CHOLESTASIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
CHOLESTASIS OF PREGNANCY  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
DRUG-INDUCED LIVER INJURY  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
HEPATIC FUNCTION ABNORMAL  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
HEPATITIS  1  1/1121 (0.09%)  1 3/1541 (0.19%)  3 0/298 (0.00%)  0
HEPATORENAL FAILURE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
JAUNDICE  1  1/1121 (0.09%)  1 2/1541 (0.13%)  2 0/298 (0.00%)  0
PORTAL HYPERTENSION  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
Immune system disorders       
ANAPHYLACTIC REACTION  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
ANAPHYLACTIC SHOCK  1  1/1121 (0.09%)  1 2/1541 (0.13%)  2 0/298 (0.00%)  0
ANAPHYLACTOID REACTION  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
DRUG HYPERSENSITIVITY  1  4/1121 (0.36%)  4 11/1541 (0.71%)  11 0/298 (0.00%)  0
HYPERSENSITIVITY  1  0/1121 (0.00%)  0 7/1541 (0.45%)  7 0/298 (0.00%)  0
INTESTINE TRANSPLANT REJECTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
SERUM SICKNESS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  1
TYPE IV HYPERSENSITIVITY REACTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
Infections and infestations       
ABDOMINAL ABSCESS  1  7/1121 (0.62%)  8 20/1541 (1.30%)  23 2/298 (0.67%)  3
ABDOMINAL SEPSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ABDOMINAL WALL ABSCESS  1  1/1121 (0.09%)  1 4/1541 (0.26%)  4 0/298 (0.00%)  0
ABSCESS  1  10/1121 (0.89%)  11 10/1541 (0.65%)  10 1/298 (0.34%)  1
ABSCESS INTESTINAL  1  1/1121 (0.09%)  1 4/1541 (0.26%)  5 3/298 (1.01%)  3
ABSCESS SWEAT GLAND  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
ACINETOBACTER BACTERAEMIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ACUTE SINUSITIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
ACUTE TONSILLITIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 1/298 (0.34%)  1
AMOEBIC DYSENTERY  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
ANAL ABSCESS  1  17/1121 (1.52%)  21 61/1541 (3.96%)  83 8/298 (2.68%)  12
APPENDICITIS  1  3/1121 (0.27%)  3 7/1541 (0.45%)  7 1/298 (0.34%)  1
ARTHRITIS INFECTIVE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  1
ATYPICAL PNEUMONIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
BACTERAEMIA  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
BACTERIAL PYELONEPHRITIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
BACTERIAL SEPSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
BARTHOLIN'S ABSCESS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
BRONCHITIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
BRONCHOPNEUMONIA  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
CAMPYLOBACTER GASTROENTERITIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  3 0/298 (0.00%)  0
CAMPYLOBACTER INFECTION  1  1/1121 (0.09%)  1 3/1541 (0.19%)  3 0/298 (0.00%)  0
CELLULITIS  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 0/298 (0.00%)  0
CHLAMYDIAL INFECTION  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
CHRONIC SINUSITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
CHRONIC TONSILLITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
CLOSTRIDIUM DIFFICILE COLITIS  1  1/1121 (0.09%)  1 4/1541 (0.26%)  4 0/298 (0.00%)  0
CLOSTRIDIUM DIFFICILE INFECTION  1  0/1121 (0.00%)  0 5/1541 (0.32%)  5 1/298 (0.34%)  1
CYSTITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
CYTOMEGALOVIRUS COLITIS  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  2
CYTOMEGALOVIRUS HEPATITIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
CYTOMEGALOVIRUS INFECTION  1  5/1121 (0.45%)  5 4/1541 (0.26%)  5 0/298 (0.00%)  0
DIARRHOEA INFECTIOUS  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
DIVERTICULITIS  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
ENDOCARDITIS STAPHYLOCOCCAL  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ENTEROCOLITIS INFECTIOUS  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
EPSTEIN-BARR VIRUS INFECTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ERYSIPELAS  1  1/1121 (0.09%)  1 3/1541 (0.19%)  3 0/298 (0.00%)  0
ESCHERICHIA BACTERAEMIA  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
ESCHERICHIA SEPSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ESCHERICHIA URINARY TRACT INFECTION  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
FEBRILE INFECTION  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
GASTROENTERITIS  1  9/1121 (0.80%)  9 16/1541 (1.04%)  16 2/298 (0.67%)  2
GASTROENTERITIS PSEUDOMONAS  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
GASTROENTERITIS SALMONELLA  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
GASTROENTERITIS VIRAL  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 0/298 (0.00%)  0
GASTROINTESTINAL INFECTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
GENITAL ABSCESS  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
GENITOURINARY TRACT INFECTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
GIARDIASIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
GROIN ABSCESS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
HAEMATOMA INFECTION  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
HEPATITIS E  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
HERPES VIRUS INFECTION  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
HERPES ZOSTER  1  1/1121 (0.09%)  1 5/1541 (0.32%)  5 1/298 (0.34%)  1
HERPES ZOSTER OPHTHALMIC  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
HORDEOLUM  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
HUMAN HERPESVIRUS 6 INFECTION  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
INFECTION  1  2/1121 (0.18%)  2 2/1541 (0.13%)  2 0/298 (0.00%)  0
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
INFECTIVE THROMBOSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LARYNGITIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  3 0/298 (0.00%)  0
LISTERIOSIS  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
LIVER ABSCESS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LOBAR PNEUMONIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LOWER RESPIRATORY TRACT INFECTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LUNG ABSCESS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LUNG INFECTION  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
MENINGITIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
MENINGITIS LISTERIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MENINGITIS STAPHYLOCOCCAL  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MENINGITIS VIRAL  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
MENINGOENCEPHALITIS BACTERIAL  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MYCOBACTERIAL INFECTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MYCOPLASMA INFECTION  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
NASOPHARYNGITIS  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
ORAL HERPES  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
OTITIS MEDIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
OVARIAN ABSCESS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PAPILLOMA VIRAL INFECTION  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
PARONYCHIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PELVIC ABSCESS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
PERINEAL ABSCESS  1  1/1121 (0.09%)  1 4/1541 (0.26%)  5 0/298 (0.00%)  0
PERIRECTAL ABSCESS  1  1/1121 (0.09%)  1 6/1541 (0.39%)  6 0/298 (0.00%)  0
PERITONEAL ABSCESS  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
PERITONITIS  1  1/1121 (0.09%)  1 7/1541 (0.45%)  8 1/298 (0.34%)  1
PERITONSILLAR ABSCESS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PHARYNGITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PILONIDAL CYST  1  2/1121 (0.18%)  2 3/1541 (0.19%)  4 0/298 (0.00%)  0
PNEUMONIA  1  5/1121 (0.45%)  5 14/1541 (0.91%)  15 2/298 (0.67%)  2
PNEUMONIA MYCOPLASMAL  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
POST PROCEDURAL SEPSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
POSTOPERATIVE ABSCESS  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 0/298 (0.00%)  0
POSTOPERATIVE WOUND INFECTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PSEUDOMEMBRANOUS COLITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PSOAS ABSCESS  1  1/1121 (0.09%)  1 3/1541 (0.19%)  3 0/298 (0.00%)  0
PULMONARY TUBERCULOSIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
PURULENT DISCHARGE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PYELONEPHRITIS  1  1/1121 (0.09%)  1 4/1541 (0.26%)  4 2/298 (0.67%)  2
RECTAL ABSCESS  1  1/1121 (0.09%)  1 7/1541 (0.45%)  8 0/298 (0.00%)  0
RECTOVAGINAL SEPTUM ABSCESS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
RETROPERITONEAL ABSCESS  1  2/1121 (0.18%)  2 1/1541 (0.06%)  1 0/298 (0.00%)  0
SALMONELLOSIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
SALPINGITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  2 0/298 (0.00%)  0
SEPSIS  1  2/1121 (0.18%)  2 7/1541 (0.45%)  7 0/298 (0.00%)  0
SEPTIC SHOCK  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
SINUSITIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 1/298 (0.34%)  1
SKIN INFECTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
STAPHYLOCOCCAL INFECTION  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
STITCH ABSCESS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
SUBCUTANEOUS ABSCESS  1  2/1121 (0.18%)  2 8/1541 (0.52%)  8 1/298 (0.34%)  1
TONSILLITIS  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
TOOTH ABSCESS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
TOXOPLASMOSIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
TUBERCULOSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  2
TUBERCULOSIS GASTROINTESTINAL  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
URINARY TRACT INFECTION  1  1/1121 (0.09%)  1 5/1541 (0.32%)  5 0/298 (0.00%)  0
URINARY TRACT INFECTION BACTERIAL  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
UROSEPSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
VAGINAL ABSCESS  1  3/1121 (0.27%)  3 1/1541 (0.06%)  1 0/298 (0.00%)  0
VAGINAL INFECTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
VIRAL DIARRHOEA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
VIRAL INFECTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
VIRAL PERICARDITIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
VULVAL ABSCESS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
WOUND INFECTION  1  2/1121 (0.18%)  2 3/1541 (0.19%)  3 1/298 (0.34%)  1
Injury, poisoning and procedural complications       
ANASTOMOTIC COMPLICATION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ANASTOMOTIC FISTULA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ANASTOMOTIC LEAK  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ANASTOMOTIC STENOSIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
ANKLE FRACTURE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
CERVICAL VERTEBRAL FRACTURE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
CRANIOCEREBRAL INJURY  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
EXPOSURE DURING PREGNANCY  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 5/298 (1.68%)  5
FACIAL BONES FRACTURE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
FALL  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
FEMORAL NECK FRACTURE  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 1/298 (0.34%)  1
FEMUR FRACTURE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  2
FIBULA FRACTURE  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
FOOT FRACTURE  1  2/1121 (0.18%)  2 0/1541 (0.00%)  0 0/298 (0.00%)  0
FRACTURE  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
GASTROINTESTINAL ANASTOMOTIC LEAK  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
GASTROINTESTINAL STOMA COMPLICATION  1  1/1121 (0.09%)  1 7/1541 (0.45%)  8 1/298 (0.34%)  2
HEAD INJURY  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
HEPATIC HAEMATOMA  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
HEPATIC RUPTURE  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
HUMERUS FRACTURE  1  1/1121 (0.09%)  1 2/1541 (0.13%)  2 0/298 (0.00%)  0
INCISIONAL HERNIA  1  2/1121 (0.18%)  3 4/1541 (0.26%)  4 0/298 (0.00%)  0
INFUSION RELATED REACTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
JAW FRACTURE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LACERATION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LIMB INJURY  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
LIMB TRAUMATIC AMPUTATION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MENISCUS INJURY  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
MULTIPLE FRACTURES  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
OVERDOSE  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
POISONING  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
POST PROCEDURAL COMPLICATION  1  3/1121 (0.27%)  3 3/1541 (0.19%)  3 0/298 (0.00%)  0
POST PROCEDURAL DIARRHOEA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
POST PROCEDURAL HAEMATOMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
POST PROCEDURAL HAEMORRHAGE  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 0/298 (0.00%)  0
POSTOPERATIVE FEVER  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
POSTOPERATIVE HERNIA  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
POSTOPERATIVE ILEUS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
POSTOPERATIVE WOUND COMPLICATION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PROCEDURAL COMPLICATION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PROCEDURAL PAIN  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PROCEDURAL SITE REACTION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
RADIUS FRACTURE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
RIB FRACTURE  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
ROAD TRAFFIC ACCIDENT  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
SEROMA  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
SKULL FRACTURE  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
SPINAL FRACTURE  1  3/1121 (0.27%)  3 0/1541 (0.00%)  0 0/298 (0.00%)  0
SPLENIC RUPTURE  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
SUBCUTANEOUS HAEMATOMA  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
SUTURE RELATED COMPLICATION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
TENDON INJURY  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
TENDON RUPTURE  1  1/1121 (0.09%)  1 2/1541 (0.13%)  2 0/298 (0.00%)  0
THERMAL BURN  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
THORACIC VERTEBRAL FRACTURE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
TIBIA FRACTURE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
TOOTH INJURY  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
TOXICITY TO VARIOUS AGENTS  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
UPPER LIMB FRACTURE  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
WOUND COMPLICATION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  2 0/298 (0.00%)  0
Investigations       
BIOPSY LIVER  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
BLOOD SODIUM DECREASED  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
BODY TEMPERATURE INCREASED  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
CYTOMEGALOVIRUS TEST  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
FALSE POSITIVE INVESTIGATION RESULT  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
HEPATIC ENZYME INCREASED  1  0/1121 (0.00%)  0 1/1541 (0.06%)  2 0/298 (0.00%)  0
INVESTIGATION  1  1/1121 (0.09%)  1 2/1541 (0.13%)  2 0/298 (0.00%)  0
LIVER FUNCTION TEST ABNORMAL  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
NOROVIRUS TEST POSITIVE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
VOLUME BLOOD DECREASED  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
WEIGHT DECREASED  1  2/1121 (0.18%)  2 2/1541 (0.13%)  3 0/298 (0.00%)  0
Metabolism and nutrition disorders       
DECREASED APPETITE  1  1/1121 (0.09%)  2 0/1541 (0.00%)  0 0/298 (0.00%)  0
DEHYDRATION  1  2/1121 (0.18%)  2 11/1541 (0.71%)  27 3/298 (1.01%)  3
DIABETES MELLITUS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  1
ELECTROLYTE IMBALANCE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
FLUID RETENTION  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
FOOD INTOLERANCE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
HYPOCALCAEMIA  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
HYPOGLYCAEMIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
HYPOKALAEMIA  1  1/1121 (0.09%)  1 3/1541 (0.19%)  4 1/298 (0.34%)  2
HYPOPHAGIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MALNUTRITION  1  1/1121 (0.09%)  1 3/1541 (0.19%)  5 1/298 (0.34%)  1
METABOLIC ACIDOSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
OBESITY  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
OVERWEIGHT  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
VITAMIN K DEFICIENCY  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  1/1121 (0.09%)  1 9/1541 (0.58%)  11 1/298 (0.34%)  1
ARTHRITIS  1  1/1121 (0.09%)  2 3/1541 (0.19%)  3 0/298 (0.00%)  0
ARTHRITIS ENTEROPATHIC  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
ARTHRITIS REACTIVE  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
BACK PAIN  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 0/298 (0.00%)  0
BURSITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  1
CHONDROPATHY  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
FIBROMYALGIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  7 0/298 (0.00%)  0
FISTULA  1  6/1121 (0.54%)  6 17/1541 (1.10%)  17 2/298 (0.67%)  3
FISTULA DISCHARGE  1  4/1121 (0.36%)  4 5/1541 (0.32%)  5 0/298 (0.00%)  0
FLANK PAIN  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
FOOT DEFORMITY  1  1/1121 (0.09%)  1 3/1541 (0.19%)  3 0/298 (0.00%)  0
FRACTURE DELAYED UNION  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
INTERVERTEBRAL DISC PROTRUSION  1  2/1121 (0.18%)  2 3/1541 (0.19%)  3 1/298 (0.34%)  1
JOINT STIFFNESS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LUMBAR SPINAL STENOSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LUPUS-LIKE SYNDROME  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
METATARSALGIA  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
MONARTHRITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MUSCLE ATROPHY  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MUSCULOSKELETAL CHEST PAIN  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
MUSCULOSKELETAL PAIN  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  1
MYALGIA  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
OSTEONECROSIS  1  4/1121 (0.36%)  4 1/1541 (0.06%)  1 0/298 (0.00%)  0
PATHOLOGICAL FRACTURE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PERIARTHRITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  2 0/298 (0.00%)  0
POLYARTHRITIS  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
RHABDOMYOLYSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ROTATOR CUFF SYNDROME  1  1/1121 (0.09%)  1 2/1541 (0.13%)  2 0/298 (0.00%)  0
SLE ARTHRITIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
SPINAL OSTEOARTHRITIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
SPONDYLITIS  1  2/1121 (0.18%)  2 2/1541 (0.13%)  2 1/298 (0.34%)  1
SYNOVITIS  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
SYSTEMIC LUPUS ERYTHEMATOSUS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
TRISMUS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
ABDOMINAL NEOPLASM  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
ACUTE LEUKAEMIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ACUTE MYELOID LEUKAEMIA  1  1/1121 (0.09%)  1 2/1541 (0.13%)  2 0/298 (0.00%)  0
ADENOCARCINOMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ADENOCARCINOMA GASTRIC  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ADENOCARCINOMA OF COLON  1  1/1121 (0.09%)  2 3/1541 (0.19%)  3 0/298 (0.00%)  0
ANAL CANCER  1  2/1121 (0.18%)  2 0/1541 (0.00%)  0 0/298 (0.00%)  0
ANOGENITAL WARTS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
B-CELL LYMPHOMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
BASAL CELL CARCINOMA  1  1/1121 (0.09%)  1 3/1541 (0.19%)  3 0/298 (0.00%)  0
BENIGN NEOPLASM  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
BENIGN SOFT TISSUE NEOPLASM  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
BENIGN UTERINE NEOPLASM  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
BLADDER TRANSITIONAL CELL CARCINOMA  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
BRAIN NEOPLASM  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
BREAST CANCER  1  3/1121 (0.27%)  3 5/1541 (0.32%)  5 0/298 (0.00%)  0
CERVIX CARCINOMA  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
CHRONIC MYELOID LEUKAEMIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
COLON CANCER  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 0/298 (0.00%)  0
ENDOMETRIAL CANCER  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
GASTROINTESTINAL NEOPLASM  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
GASTROINTESTINAL TRACT ADENOMA  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
HODGKIN'S DISEASE  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 0/298 (0.00%)  0
LARYNGEAL CANCER  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
LUNG CANCER METASTATIC  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LUNG NEOPLASM MALIGNANT  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 1/298 (0.34%)  1
LYMPHOMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
LYMPHOPROLIFERATIVE DISORDER  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
MALIGNANT NEOPLASM OF UNKNOWN PRIMARY SITE  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
MALIGNANT PERITONEAL NEOPLASM  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
MELANOCYTIC NAEVUS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
MENINGIOMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
METASTASES TO LIVER  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
METASTASIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
METASTATIC LYMPHOMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
NON-HODGKIN'S LYMPHOMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
NON-SMALL CELL LUNG CANCER METASTATIC  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
OESOPHAGEAL CARCINOMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
OVARIAN ADENOMA  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
OVARIAN CANCER  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
PANCREATIC CARCINOMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PROSTATE CANCER  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
RECTAL ADENOCARCINOMA  1  1/1121 (0.09%)  1 2/1541 (0.13%)  2 1/298 (0.34%)  1
RECTAL ADENOMA  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
RECTAL CANCER  1  0/1121 (0.00%)  0 3/1541 (0.19%)  3 0/298 (0.00%)  0
RENAL CANCER  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
SKIN CANCER  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
SMALL INTESTINE ADENOCARCINOMA  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 1/298 (0.34%)  1
SMALL INTESTINE CARCINOMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
SQUAMOUS CELL CARCINOMA  1  2/1121 (0.18%)  2 1/1541 (0.06%)  1 0/298 (0.00%)  0
THYROID ADENOMA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
THYROID NEOPLASM  1  0/1121 (0.00%)  0 0/1541 (0.00%)  0 1/298 (0.34%)  1
URETERIC CANCER  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
UTERINE CANCER  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
UTERINE LEIOMYOMA  1  2/1121 (0.18%)  2 3/1541 (0.19%)  3 1/298 (0.34%)  1
VULVAL CANCER STAGE 0  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
Nervous system disorders       
CEREBRAL ARTERY THROMBOSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
CEREBRAL ATROPHY  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
CEREBRAL HAEMORRHAGE  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
CEREBROVASCULAR ACCIDENT  1  2/1121 (0.18%)  2 1/1541 (0.06%)  1 1/298 (0.34%)  1
COMPLEX REGIONAL PAIN SYNDROME  1  0/1121 (0.00%)  0 1/1541 (0.06%)  2 0/298 (0.00%)  0
EPILEPSY  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 1/298 (0.34%)  1
GRAND MAL CONVULSION  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
HEADACHE  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
INTRACRANIAL ANEURYSM  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
ISCHAEMIC STROKE  1  1/1121 (0.09%)  1 3/1541 (0.19%)  4 0/298 (0.00%)  0
LOSS OF CONSCIOUSNESS  1  1/1121 (0.09%)  1 1/1541 (0.06%)  1 0/298 (0.00%)  0
MIGRAINE  1  1/1121 (0.09%)  1 0/1541 (0.00%)  0 0/298 (0.00%)  0
NERVE ROOT COMPRESSION  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
NEUROLOGICAL SYMPTOM  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
OPTIC NEURITIS  1  0/1121 (0.00%)  0 2/1541 (0.13%)  2 0/298 (0.00%)  0
PARAESTHESIA  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0
PARALYSIS  1  0/1121 (0.00%)  0 1/1541 (0.06%)  1 0/298 (0.00%)  0